2005 - OFF TOPIC
Growing biotech blood vessels
Richard Halstead
Note: A link to their home page is at the
end of this post ....
Tucked away on the second floor of an airplane hangar at Hamilton Field in Novato, behind the doors of a typical-looking office, white-gowned technicians in a glass-walled, air-tight, biological clean room manipulate long glass tubes containing stainless steel rods.
The scene, resembling an outtake from a James Bond movie, requires no phone call to the Department of Homeland Security.
The laboratory belongs to Cytograft, a fledgling biotechnology company that hopes to crack a multibillion-dollar market by growing blood vessels.
The company began human trials of its blood vessels in Argentina earlier this year.
It received national attention last week when it presented the early results of those trials at an American Heart Association conference in Dallas.
"It's an exceptional success story," said Martha Lundberg, a health scientist administrator with the National Institutes of Health, which has poured more than $3 million into the company's work.
Cytograft grows the new blood vessels from tiny pieces of skin and vein taken from the person in which they will eventually be implanted. Initial beneficiaries include diabetics and heart bypass patients.
The blood vessels could be used in place of synthetic shunts for hemodialysis access. They could also be employed in coronary bypass operations to reroute blood flow around blockages.
"These are huge, multibillion-dollar markets," said Nicolas L'Heureux, who co-founded the company with Todd McAllister.
The two 39-year-old scientists met at the University of California at San Diego during the late 1990s when L'Heureux, a cell biologist, was completing his post-doctorate work and McAllister, a bioengineer, was a graduate student. They currently oversee eight employees.
Cytograft's "home-grown" approach is something of a departure in the field of bioengineering. Past efforts to create blood vessel replacements focused on plastic devices. The accepted wisdom was the devices needed to be one-size-fits-all and cheap to make.
L'Heureux, who grew up in Canada and sports a short pony-tail with his pin-striped suit, had another vision.
"I decided we would try to make the best vessel we could," L'Heureux said. "It would take time and it would be done for every individual, and it would be more costly than a tube of plastic. But, if it works, you can justify all that."
It takes six to nine months for Cytograft to produce a new blood vessel. The process begins with the construction of the outer walls of the vein. A tiny piece of skin taken from the recipient is placed in a lab dish and nurtured with growth enhancers. From it, numerous sheets of new skin are produced.
"From one little biopsy, we grow 14 of these flasks," L'Heureux said, pointing to flasks containing growing skin. "We could grow much, much more than that. We could grow 10 times as much, easily."
The sheets, which consist mainly of living tissue and collagen, are stacked and rolled around stainless steel rods to form the outer wall of the new vessel. Later, cells from the interior of the recipient's vein will be inserted to provide the lining. It's these cells that prevent the blood vessel from clotting.
The final result is a new vessel that will not be rejected by the recipient's body, as are synthetic devices. In fact, there is reason to believe the body will interact with the vessel naturally, bathing it with enzymes that will allow it to grow and become more flexible, L'Heureux said.
"Pretty much nobody else has pursued this," Lundberg said. "It's very new, very novel."
Eventually, nine kidney dialysis patients will participate in the Argentine human trial, which began in May. The company also is enrolling patients for a 25-patient study in the United Kingdom in which Cytograft blood vessels will be used to replace radial arteries that have been removed from patients' arms for use in heart bypass surgery.
"If that works well, that's a good argument to say we can do heart bypass," L'Heureux said.
Safety trials in the United States are expected to begin in 2007, Lundberg said.
If all goes well, McAllister predicts Cytograft will have its first commercial sales in Europe in the first quarter of 2007.
He expects to charge $20,000 for each lab-grown vessel.
That might sound pricey, McAllister says, until you consider that Medicare spends $4 billion to $5 billion annually to implant and maintain synthetic shunts in end-stage renal disease patients.
"They're paying to clear these things out," McAllister said, referring to the synthetic shunts. "These interventions cost about $8,000 per procedure. If the patient gets infected, the treatment costs about $25,000 per patient."
McAllister estimates that over a three- to five-year period, the lab-grown vessels would save Medicare $20,000 per renal disease patient.
Starting a biotech company requires a laboratory and plenty of expensive equipment.
"It's not like building a computer," L'Heureux said. "You can't do it in a garage."
Nevertheless, Cytograft has been very frugal.
"We've come all the way from starting the company to clinical trials on $5.5 million of private money," L'Heureux said.
L'Heureux and McAllister founded the company in 1999 with $100,000 from the NIH and a $10,000 doctorate thesis award from Merrill Lynch. In 2000, McAllister came to the Bay Area and secured a $1 million investment from a cardiac physician, who prefers to remain anonymous.
"I came here to be part of the entrepreneurial boom," McAllister said.
The company is seeking its fourth round of financing. L'Heureux believes the company's quarters in Novato should accommodate its growth for at least the next five years.
McAllister said Cytograft could become a public company some day. It is more likely, however, that Cytograft will be acquired by a larger company, he said.
But neither L'Heureux nor McAllister is looking that far ahead.
"Many, many companies just flame out," L'Heureux said. "They get $50 million. They start staying at four-star hotels and going to every meeting in the world.
"We want to walk before we run."
marinij.com
Their home page ....
cytograft.com
From the Investors Link on their Web Site .....
Investor Relations
Cytograft Tissue Engineering is a privately held corporation.
CTE is currently raising $15M to support expanded clinical trials. Accredited or institutional investors may contact CEO Todd McAllister at todd@cytograft.com for more information.
Lifeline is targeted at three distinct patient populations;
A-V shunts for hemodialysis patients,
peripheral bypass grafts for lower limb amputation candidates,
and coronary artery bypass grafts for coronary bypass revision patients.
Collectively, these markets represent over $5 billion annually in the U.S. alone.
AV-Shunt
The vast majority of End Stage Renal Disease (ESRD) patients are treated with hemodialysis. Hemodialysis requires vascular access through a permanent A-V fistula (where native veins are re-routed to connect to a native artery) or A-V shunt (where a synthetic conduit shunts arterial blood flow directly to the venous return). Twenty-five percent of the total cost to treat ESRD is directly attributed to vascular access. There are currently over 300,000 ESRD patients in the U.S., and this patient population is growing by ~10% annually. Risk factors for ESRD (such as diabetes) are also growing, suggesting that the vascular access market for ESRD/hemodialysis patients will continue to grow.
Peripheral Bypass
Each year, over 130,000 lower limb amputations are performed due to poor vascularization. Although studies demonstrate that revascularization is both cost effective and improves patient quality of life, lack of suitable small diameter graft material prohibits many of these patients from revascularization options. Like ESRD, the primary risk factor for lower limb amputation is diabetes, a disease which now afflicts over 3 million Americans. With the increase in incidence of diabetes and other cardiovascular risk factors, the market for lower limb revascularization is likely to continue to grow.
Coronary Artery Bypass
Over 600,000 coronary artery grafts are placed each year in the United States. About 20% of these procedures are revisions (secondary procedures). Due to previous harvest or disease progress, suitable native vessels may not be available for these revision candidates. 50,000-100,000 revision candidates die annually in the United States due to lack of suitable graft vessels. This population is likely to increase, following 10-12 years behind the explosive growth in primary procedures in the late 1980’s and 1990’s. Cytograft Tissue Engineering’s Lifeline™ technology will be applied to this market as soon as efficacy is demonstrated in the less critical peripheral circulation.
cytograft.com
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